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N-Acetylcysteine and Arginine Administration in Diabetic Patients (NACARGPAO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00569465
Recruitment Status : Terminated (End of the study)
First Posted : December 7, 2007
Last Update Posted : December 7, 2007
Information provided by:
University of Turin, Italy

Brief Summary:

It has been demonstrated that the nitric oxide production is reduced in type 2 diabetic patients and that cardiovascular complications represent 80% of the causes of death in these patients. As nitric oxide is able to reduce platelet aggregation, increase the relaxation of smooth muscle cells, and reduce plasminogen activator inhibitor-1 and endothelin, we hypothesized that nitric oxide deficiency is responsable for the cardiovascular disease in type 2 diabetes mellitus. Arginine and N-acetylcysteine, precursor and enhancer of the nitric oxide synthesis respectively, are able to increase nitric oxide production.

Aim of the study is to evaluate the effect of arginine and N-acetylcysteine administration on arterial blood pressure and different metabolic parameters in patients with type 2 diabetes mellitus and hypertension.

Subjects and methods. 24 male subjects, randomly divided in two groups, will be studied. These subjects will undergo a treatment with arginine (1200 mg once a day) plus N-acetylcysteine (600 mg twice a day) or placebo for six months. Basal and final evaluations include:

  • general examination
  • ABPM (ambulatory blood pressure monitoring)
  • HbA1c, total-cholesterol, HDL-cholesterol, LDL-cholesterol, oxidized LDLs, triglycerides, reduced/oxidized glutathione ratio in red blood cells, nitrites/nitrates, asymmetrical and symmetrical dimethyl-arginine, nitrotyrosine, arginine, homocysteine, C-reactive protein, interleukin-6, tumor necrosis factor-α, intercellular and vascular-cell adhesion molecules, plasminogen activator inhibitor-1 and fibrinogen
  • the ultrasound assessment of the intima-media thickness after endothelium-dependent flow-mediated vasodilation of the brachial artery

Expected results. Increase of nitric oxide production and reduction of arterial blood pressure and oxidative parameters.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Hypertension Drug: Arginine Drug: Acetylcysteine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Arginine and N-Acetylcysteine Administration on Nitric Oxide Production and Arterial Blood Pressure in Hypertensive Diabetic Patients.
Study Start Date : January 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: A Drug: Placebo
3 vials a day

Experimental: B Drug: Arginine
1200 mg, once a day
Other Name: Zentrum

Drug: Acetylcysteine
600 mg twice a day
Other Name: Acetilcisteina

Primary Outcome Measures :
  1. arterial blood pressure decrease [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. oxidative parameters decrease [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male subjects
  • Age between 40 and 70 years
  • Type 2 diabetes mellitus and hypertension
  • Mean 24h arterial blood pressure after the wash-out period: systolic >136mmHg and/or diastolic >86 mmHh
  • Written informed consent

Exclusion Criteria:

  • Female subjects
  • Mean 24h arterial blood pressure after the wash-out period: systolic >180 mmHg and/or diastolic >110 mmHg
  • Secondary hypertension
  • Significative cardiovascular complications of diabetes
  • Cancer or severe systemic, hepatic, pulmonary, cardiovascular or diseases
  • Actual treatment with nitrates, acetylcysteine or arginine
  • Acetylcysteine hypersensitivity
  • Psychiatric disturbs, abuse of drugs or alcohol
  • Low compliance
  • Absence of written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00569465

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"San Giovanni Battista" Hospital of Turin
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy
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Principal Investigator: Valentino Martina, MD University of Turin, Italy
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Responsible Party: Prof. Valentino Martina, University of Turin Identifier: NCT00569465    
Other Study ID Numbers: EUDRACT 2004-004203-38
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: December 2007
Keywords provided by University of Turin, Italy:
nitric oxide
oxidative stress
endothelial dysfunction
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs